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Executives

Albert Fleury – Director IR North America

Peer Schatz – Chief Executive Officer

Roland Sackers – Chief Financial Officer

John Gilardi – Vice President and Corporate Communications and Investor Relations

Analysts

Quintin Lai – Robert W. Baird

Doug Schenkel – Cowen and Company

Nandita Koshal – Barclays Capital

Tycho Peterson – JPMorgan

Jon Groberg – Macquarie

Martin Wales – UBS

Bill Quirk – Piper Jaffray

Romain Zana – Exane BNP Paribas

Peter Lawson – Mizuho Securities

QIAGEN N.V. (QGEN) Q4 2011 Earnings Conference Call February 1, 2012 9:30 AM ET

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the QIAGEN NV Investor and Analyst Conference Call on the Q4 Results 2011. Throughout today's recorded presentation, all participants will be in a listen-only mode. The presentation will be followed by a question-and-answer session. (Operator Instruction)

I would now like to turn the conference over to Albert Fleury, Director IR North America.

Albert Fleury – Director IR

Thank you. Good afternoon and welcome to the QIAGEN conference call to discuss our results for the fourth quarter and full year 2011. Joining me on the call are Peer Schatz, Chief Executive Officer, Roland Sackers, Chief Financial Officer and John Gilardi, Vice President and Corporate Communications and Investor Relations. A copy of this announcement and the presentation for this conference call can be downloaded from the Investor Relations section of our homepage at www.qiagen.com.

Moving onto Slide 2, before I turn the call over to Peer, please keep in mind that the following discussion and the responses to our questions reflect management’s view as of today, February 1, 2011. As we share information to help you better understand our business, we will make statements and provide responses that state our intentions, beliefs, expectations, or predictions of the future. These constitute forward-looking statements for the purpose of the Safe Harbor provision. These involve certain risks and uncertainties that could cause QIAGEN’s actual results to differ materially from those projected. QIAGEN disclaims any intention or obligation to revise any forward-looking statements. For a compete description of the risks and uncertainties, please refer to our Form 20-F filed with the U.S. Securities and Exchange Commission.

I would now like to turn this call over to Peer.

Peer Schatz – Chief Executive Officer

Thank you, Al. I would like to welcome all of you to our conference call and the opportunity to discuss our results for the fourth quarter and full year 2011. As you saw in our release last night, we delivered dynamic growth in the fourth quarter. Net sales were up 17% at constant exchange rates to $334 million by adjusted net income rose 19% to $74 million and adjusted EPS came in at $0.31 per share.

The strong finish led to net sales growth of 4% in the constant exchange rate basis for the full year to $1.17 billion. An adjusted EPS for the full year rose to $0.98. We achieve these results, which were ahead of our goals against the backdrop of a challenging business environment when they did not improve during the course of the year.

The key driver has been our progress on four strategic initiatives. Number one, we are driving platform success, especially with the rollout of the breakthrough QIAsymphony automation platform. Number two, we are adding content across all of our customer classes. Number three, we are expanding our geographic presence especially in high growth markets. And number four; we are improving our efficiency and effectiveness. We are clearly not growing yet at a rate that we believe our company can deliver, but our strategic initiatives are on track to get there. And achieving these results in 2011 was an important step of course to accelerate full year sales growth to faster pace in 2012.

Moving to Slide 5, you can see that we achieved our goals deliver markedly improved year-on-year performance in the second half of 2011, compared to the first half. We had said previously that the second half of 2011, we provide a proxy as to how we believed growth could accelerate for the full year in 2011 and 2012.

Our sales growth in the second half of the year was above our target of around 7% on a constant exchange rate basis. With the second half, organic growth improved and contributed about 4 percentage points, while the Cellestis and Ipsogen acquisitions have been performing very well and they contributed about 5 percentage points. So, this total sales performance helps our confidence for accelerating growth in 2012, but again we are taking conservative perspective given the ongoing challenging environment.

I’m now on Slide 6, to review a few achievements in 2011 against our strategic initiatives I described before. In terms of driving platform success, we achieved our goal for more than 550 installed QIAsymphony systems worldwide at the end of 2011. We are very pleased with the rollout and our only in the early years of a decade long product cycle. Also in late 2011, we introduced the QIAensemble Decapper system that automates the tedious task of manually handling clinical liquid sample vials.

Based on recent industry announcements, it is worth noting that both QIAsymphony and QIAensemble Decapper receive very strong endorsements by customers. Even competitors for instance now recognized that, for instance the QIAensemble Decapper system addresses a significant gap in the liquid cytology vial processing and some are seeking to create their own systems a very significant undertaking.

In terms of adding content, we have been very active in Personalized Healthcare. In the U.S., we completed our two submissions of the therascreen KRAS assay as a companion diagnostic. Discussions with the FDA are progressing well and we anticipate receiving decisions in mid-2012. We also added new co-development projects during 2011 that will lead to regulatory submissions in the future.

In terms of geographic expansion, you saw in our release that the top seven emerging markets are delivering dynamic growth. We entered India and Taiwan with our own operations in 2011. And in terms of growing efficiently and effectively, we launched a major efficiency project at the end of 2011. We streamlined our organization and are now working to free up additional resources that can be reallocated to this growth initiatives. These actions will help improve our adjusted operating income margin in 2013.

In summary, we made significant progress in 2011 on these four initiatives and are intensifying our focus on growth areas across all customer classes.

I would like to hand over to Roland for a review of our financial performance. Roland?

Roland Sackers – Chief Financial Officer

Thank you, Peer and good afternoon to everyone in Europe. Good morning to those joining from the U.S. Starting on slide 7, I would like to first cover the fourth quarter financial results before going onto our full year review. The first quarter of 2011 for QIAGEN exceeded our expectation both in terms of net sales and adjusted EPS.

Recapping the key figures; net sales in the fourth quarter rose 17% both on a reported as well as at constant exchange rates for approximately US$334 million from the first quarter of 2010. Consumable sales were up 18% constant exchange rate wise and instruments were up 11% using constant exchange rate. Moving below net sales, the adjusted gross profit was 70% to approximate US$229 million. As a result, the adjusted gross margin declined to 69% from 72% in the same period of 2010.

In the 2011 quarter, we had a very high amount of milestone payments from companion diagnostic co-development partnership. Depending on the type of co-development partnership, these milestones are recognized as revenues and then expenses incurred are booked in the cost of goods sold line. As we said in the past, the gross margin for this agreement is significantly below the company average so this was one of the primary reasons for the reduced margin about 100 to 150 basis points.

The other few reasons to notice that we reduced inventory levels in the first quarter that had been build up early in the year as a safeguard for the move of production lines to our health facility. This led to a lower utilization rate in the fourth quarter of 2011 and reduced the margin by about 50 basis points. So, this is the main reason for the reduced inventory sequentially.

Adjusted operating income rose 16% to US$96 million from US$82 million in the same period of 2010. As a result, the adjusted operating margin was steady at 29% of net sales. At the same time, this was a good increase from the 26% level in the third quarter of 2011. In addition to the impact from the companion diagnostic milestone, adjusted operating income margin observed first major investment in Cellestis to expand global sales and marketing capability.

Adjusted diluted earnings per share rose to $0.31 in the fourth quarter up from $0.26 in the same quarter of 2010. We achieved this result despite an increase in the tax rate to 22% in the fourth quarter of 2011 compared to 20% in the same period of 2010. These results also include dilution of about $0.02 per share from the Cellestis investment. In summary, the fourth quarter for QIAGEN was a solid finish for the year and ahead of our plan.

I am now on slide 8, for the quarter we delivered double-digit growth in all regions as we were particularly pleased with the both business expansion in the Europe/Middle East/Africa region. In the EMEA region, where sales rose 22% constant exchange rate. We are seeing solid growth in Molecular Diagnostics, particularly for our QIAsymphony platform and hence in this region we have a broad menu.

We saw significantly improved sales in Northern European countries, but Southern European remains a challenge. However, as we have been saying our experience to the Southern Europe is less than 5% of total sales and other areas of Europe are clearly more than offsetting this impact.

For the Asia-Pacific and Japan region, net sales rose 18% driven by strong contributions from Molecular Diagnostics and Applied Testing. Key markets delivering solid both China and Japan. We were also pleased with the momentum for QuantiFERON TB testing, the latent TB test.

In the Americas, placement of QIAsymphony system across all customer classes as well as contribution from the QuantiFERON-TB test underpinned solid growth in this region. This will be a key growth driver going forward.

HPV test sales were particularly strong in the first quarter for the Americas as a whole in part due to the timing of a national HPV tender offset of the United States. The additional sales from this tender represented about 2 percentage points of total sales for QIAGEN in the 2011 fourth quarter. But even taking this into account we were pleased with Americas performance in the fourth quarter.

In the United States, HPV sales were stable in the fourth quarter and represented about 13% of total QIAGEN sales in this period. Also still looking at Americas, Academia sales were flat in the U.S. and impacted by the ongoing budget concern. Although NIH budgets are now set for 2012 and has coming better than many had expected, our concern remains about potential budget cuts under discussion after the upcoming 2012 Presidential Election.

Moving on to slide 9, I want to briefly cover the full year 2011 key financial results. Net sales rose 4% using constant exchange rates to US$1.170 billion. So this was slightly higher than the 3% constant exchange rate growth that we have been expecting.

Adjusted operating margin was 27% of net sales down from 28% in 2010. But again keep in mind that we were able to maintain a solid margin for our making investments in QuantiFERON-TB as well as supporting direct marketing entries into India and Taiwan in 2011.

In fact the adjusted operating margin would have remained flat about 28% compared to 2010 results acquisition investment. Adjusted diluted EPS were $0.98 per share, which was also head of our target and adjusted tax rate remains steady at 24%.

Moving on to slide 10, as we announced to the market, we took action in December to improve our financing structure. As you can see on the chart, we have two convertible bonds and they remain in place.

However, we have taken action on another element. First, we have entered into a new EUR400 million revolving credit facility, or RCF, with an international bank consortium and a five year maturity. The new revolving credit facility has a very favorable pricing and an initial margin of only 80 basis points over EURIBOR. This rate is based on market standard pricing components and also our current leverage level.

We then use cash on hands and EUR$110 million from the RCF to repay the remaining balance of US$350 million due on a term loan that was due to expire in July 2012. We also cancelled our previous $150 million RCF that had not been drawn. This action has many benefits. It has extended our maturity profile given us increased flexibility, and has shortened the balance sheet.

Moving on to slide 11, you see an overview of our financial position at the end of 2011. As of December 31st, Group liquidity was approximately $276 million, which is down from approximately US$935 million and mainly due to the Cellestis and Ipsogen acquisitions as well as the repayment of the term loan.

Our equity ratio improved to 68% from 63% at the end of 2010 and leverage remained at about one times net debt to EBITDA. As for free cash flow figures are still under review and the full cash flow statement as usual will be included in the regular filing with SEC.

I would now like to hand back to Peer for a strategy update.

Peer Schatz – Chief Executive Officer

Yes, thank you, Roland and we are now on slide 12. Building on the progress of 2011, we have set goals for 2012 that will help us accelerate our performance and return to even strong growth profile. First and foremost we want to drive platform success with QIAsymphony, our top priority remains increased placements and improve the utility of this platform with an expanding menu across all customer classes.

Our goal is to reach more than 750 installed systems by the end of 2012. Another priority is to further improve automation for our gold standard HPV test building on the late 2011 launch of the QIAensemble Decapper. This is the top priority for our revised QIAensemble program. We are also looking forward to completing a number of important regulatory submissions to expand the menus of our system. The top priority is the U.S. submission of the therascreen EGFR assay as a companion diagnostic to Tomtovok, the lung cancer drug in development by Boehringer-Ingelheim. This will build on the 2011 submissions of KRAS and also the 2011 approvals of the KRAS and EGFR assays in Japan.

In terms of geographic expansion, we want to further develop our direct operations in high growth regions. Eastern Europe and Russia are top on our list. We also want to expand into untapped markets in Asia and Latin America. To grow efficiently and effectively, we are moving forward rapidly with our efficiency projects. These actions are freeing up resources to reallocate to our strategic growth initiatives.

I am now on slide 13 to give you an update on QIAsymphony. We are in the early stages of a platform in content story that will play out over the next 5 to 10 years. This will lead to increasing sales growth as we expand the menu of assays. The full version, QIAsymphony RGQ, which includes three modular elements for sample preparation, assay setup, and real-time PCR detection with the Rotor-Gene RGQ, was launched at the end of 2010. We are very pleased with the uptake. We are also saying strong growth in demand for consumables used on the system. Every placement creates an opportunity for annual consumable sales or so-called pull through of anywhere between $30,000 and $300,000.

We already have a number of customers with annual consumable levels well above $100,000 to $150,000. The conservative estimate is that the average consumable pull-through is currently about $50,000 to $60,000 per installed system. We expect this level to increase markedly during 2012 as customers increase system utilization and add more tests to the system. Majority of QIAsymphony placements in the first wave are with customers who are adding modules, in other words, full QIAsymphony RGQ systems, but full off-the-shelf systems have jumped significantly as well.

You are often asked about cannibalization of QIAsymphony and incremental sales growth. We do not see this as a major issue. Our analyses show that more than two-thirds of sales to QIAsymphony customers are incremental and building upon the earlier use of our products. As we increased the installed base and win more and more customers new to our assays and products, we see this issue becoming less and less effective. During 2012, we will be launching several new tests and also updating the software. A key element will be the expansion to enable the processing on the formalin-fixed, paraffin-embedded samples so called FFPE samples. One of the key sample types for companion diagnostics. We can then begin the migration of these companion diagnostics tests onto QIAsymphony.

Moving to slide 14, here is an overview of the content we are adding to our platforms. The addition in 2011 of the QuantiFERON based tests from Cellestis in the market leading portfolio of blood cancer assays from Ipsogen fully support our strategic initiative to add content. We are adding content across our customer classes. For example, we are adding new tests for food safety to our mericon portfolio and also expanding the portfolio for human ID in line with the internationalization of standards. And we are expanding our GeneGlobe portfolio products available for molecular pathway analysis. This is a natural fit with our biomarker activities and provides very valuable technologies for the evaluation and validation of molecular targets that could one day become companion diagnostics.

I am now on slide 15. I mentioned earlier that we are targeting expansion in high growth emerging markets. The reason is clear. We see dynamic growth potentially in emerging markets that is really only just beginning for us. In the top 7 emerging markets, we generated 12% of net sales in 2011 and grew 21% on a constant exchange rate basis. China is our largest emerging market, our second largest market overall and delivering sustained growth in 2011 and representing more than 5% of our total sales. Also of note are the rapid expansion we are experiencing in Brazil, Mexico and Turkey. So, these top 7 emerging countries are going to increase as a percentage of our total sales in the coming year. We are going to expand and invest in these and other attractive high growth markets.

I am now on slide 16. As you know, we announced a project in November 2011 to grow more efficiently and effectively. We are enhancing productivity and have a goal to free up about $50 million of pre-tax resources for reallocation to strategic initiatives. Some incremental projects were started during 2010 and 2011, but we saw at the end of that major actions were needed and that this project is there for the result.

In the first phase, we have streamlined the organization by reducing approximately 8% to 10% of the work force. These actions are not reflected in the year end 2011 numbers of employees and will become more evident with the Q1 2012 report. Teams are now working on excellence initiatives across the organization. The overall project is being managed by Senior Executive and the reports directed to me on the practice of this project.

Areas include focusing our R&D portfolio on growth areas across all customer classes. This obviously includes Personalized Healthcare as well as QIAsymphony. So, as we have been saying you will see fewer, but more substantial new product launches from QIAGEN in the coming years. We are also going to optimize capacity utilization and reviewing our site network. The project is moving more rapidly than we had anticipated and this is a reason why the $75 million restructuring charge was higher than our target and also involved more cash about 40%.

As we announced, we are planning to take an additional charge of about $20 million in 2012. We believe that the payback on these investments is very significant and these actions will help drive improvement in the adjusted operating income margin in 2013 and the coming years.

I'm now on slide 17, I wanted to spend a few minutes and provide some perspective on the situation for HPV test in the United States in light of the actions we have been taken to diversify and globalize our business. We've been saying for some time, the 2011 and 2012 years are in some ways transition year for QIAGEN. During the last 18 months, we have been addressing the impact of a markedly changed environment for HPV test sales in the United States.

We've also been preparing for new competitors which happen in the second half of 2011. As you can see, the relative contribution to QIAGEN of HPV test in the United States was about 15% in 2011 and even at only about 13% for the fourth quarter. This was down from over 20% in 2008. HPV sales in the United States declined at a modest rate in 2011 as market conversion efforts were more than offset by pricing actions taken to secure multiyear contract.

I want to make a few statements here. First, no competitor has come out with a better product either in terms of clinical data not in terms of automation, most in fact a significantly inferior clinical profile. Second, we've been saying that HPV is no longer going to be a growth driver for us, but very valuable for us in terms of critical mass and building relations with Molecular Diagnostic customers. We are determined to maintain our leadership and have a very strong competitive offering. Third, we believe the key growth drivers we have in place for more than out way concerns in 2012 about lower U.S. HPV sales.

As a leader with about 90% share in the United States, it is clear that we are going to lose some share. Pricing is under pressure since new competitors do not have a superior product and are already today offering very low prices. There is untapped market potential. The penetration rate is still below 50%, and we are cautiously optimistic about higher volumes in 2012 as a decline in doctor visits begins to stabilize at a much lower level than in recent years. We have been successful in signing many customers to new multiyear contract stressing the benefits of our Hybrid Capture 2 test as well as the risks in cost of switching. This has been accomplished with only moderate pricing concessions. This pricing pressure will continue into 2012, but this was to be expected.

Customers have repeatedly told us that they are pleased with the rapid capture system the Hybrid Capture 2 Test who wants to improve automation. So, the QIAensemble Decapper launch was a big step for and we are working on other automation initiatives that we will talk about at the appropriate time. Our growth drivers in Molecular Diagnostics, Personalized Healthcare, QuantiFERON-TB, and also the use of QIAsymphony for a virology portfolio, these are all growing at robust double-digit growth.

In Applied Testing, we are looking for return to much strong growth phase in 2012 after the disappointing flat results in 2011. The 2011 performance was in part the result of customers waiting for software releases on QIAsymphony that will have a significant value for applications in Applied Testing.

Pharma is benefiting from the demand for our GeneGlobe molecular pathway tools and we are well-positioned with our operations in China to benefit from the shift in R&D to Asia as well. We are expecting modest growth in the customer class in 2012, which takes into account the adverse impact of industry consolidation. And in Academia, we have a unique portfolio of products supporting translational medicine research and again here are well-positioned for the growth of Life Sciences research.

Given the uncertain environment in the United States and Europe, we are anticipating flat sales in this customer class. As you can see, we have a broad range of growth drivers in place. We believe the outcome in 12 months will indeed be accelerating sales growth for QIAGEN versus 2011.

I'd now like go hand back to Roland. Roland?

Roland Sackers – Chief Financial Officer

Yeah, thank you, Peer. I'm now on slide 18. I would like to review our outlook for 2012 and assumptions for adjustment to operating income. As we have been saying our goal to accelerate the growth rates for full year sales and adjusted earnings growth in 2012 compared to 2011. With the full year, we expect total sales growth about 6% to 8% using constant exchange rate based on a mix of contributions from organic growth as well as Cellestis and Ipsogen acquisition.

These estimates as usual do not take into account any acquisitions that could be done in 2012. Based on average foreign exchange rates in December 2011, our positive results will show some pressure from currency movements. We currently currency headwinds of about two to three percentage point to actual report results would then be lower than the constant exchange rate growth rate.

On adjusted EPS, we anticipated full year earnings of between US$103 and US$105. This is based on about $239 million fully diluted shares outstanding. In terms of adjustment to operating income for the full year, we expect about $21 million to $22 million for equity-based compensation, about $110 million for amortization of acquired intellectual property, about US$30 million for business integration, acquisition, and restructuring. This includes approximately US$20 million for the efficiency project also included about US$8 million for the Cellestis and Ipsogen integration.

The adjusted tax rate is expected to be about $0.21 to $0.23, which compares to 24% in 2011. I'm now on slide 19 to review our assumption for the first quarter of the year. In terms of sales for the first quarter, we expect about 8% to 9% growth using constant exchange rate. Adjusted earnings per share is expected to be about $0.20 per share. This reflects the usual trend of relatively higher cost at the start of the year, but then an improving margin profile as the year progresses. We also have here the assumptions for the adjustment to operating income, the tax rate for the first quarter in recent years has typically been about the full year average and we expect this to be the case again in the first quarter of 2012.

So we are expecting a tax rate of about 26% for the first quarter of the year. I'm now on slide 20 to review our perspectives on the adjusted operating income margin before handing back to Peer. As we have been seeing, our goal is to reach 31% in the first quarter of 2013. Let me walk you through, how we expect to get that. First half actually highlighted earlier. The second half of 2011 was much stronger than the first half and ended the year with adjusted operating margin of 29% in the first quarter.

For 2012, we had set a target of about 27% to 28%. We are going to pay some pressure on gross margin, mainly due to product mix including good instrumentation growth and milestone from companion diagnostic core development yields. This will be to a lesser degree than this will be to a lesser degree than we had seen in the first quarter of 2011. On the operational expense side, we expect meaningful contributions from SG&A, which should give us higher margin at the end of 2012. As an aside, keep in mind that the timing of milestones for companion diagnostic co-development projects can be difficult to predict. And this can insert some volatility into our results on a quarterly basis.

We expect to get benefits in 2013 from the efficiency project. Just as an example, a key margin driver is expected to be the full integration of procurement. We have now created one global team handling all procurement activities across the company and we believe this will help generate even more savings. We are going to improve the margin while investing in our businesses and accelerating sales growth.

With that, I would now like to hand back to Peer.

Peer Schatz – Chief Executive Officer

Thank you, Roland. And I am now on slide 21 for the summary before we move into Q&A. We had a strong finish into 2011 achieving our goals for faster growth in the second half of the year against the backdrop of a continuing challenging business environment.

As we begin 2012, we are intensifying our focus on accelerating full year growth rates. Critical to achieving this goal, we'll be making further progress on our strategic initiatives. We are creating a foundation for future growth by the ongoing strong rollout of QIAsymphony and we are stepping up our initiatives to add content to our portfolio both internal R&D as well as through targeted acquisitions and partnerships. We are going to continue expanding our geographic presence in high growth markets, which are increasing their contributions to our results. And we will intensify our actions to improve in efficiency and effectiveness through the project we launched in late 2011.

In closing, we have shown with our results in the fourth quarter and second half of 2011 that QIAGEN is improving its performance and is ready to accelerate growth in 2012. With that, I'd like to hand back to Al to open up the Q&A session. Thank you.

Albert Fleury – Director IR

Thank you, Peer. We now look forward to taking your questions. To ensure we can accommodate as many people as possible, please limit yourself to only one question and if necessary one follow-up. Operator?

Question-and-Answer Session

Operator

Thank you. (Operator Instruction) The first question comes from Mr. Lai. Please state your name, company name, followed by your question.

Quintin Lai – Robert W. Baird

Hi, this is Quintin Lai from Robert W. Baird. Good afternoon and good morning.

Peer Schatz

Good morning, Quintin.

Quintin Lai – Robert W. Baird

So, Peer, thank you very much for all the cover on some of the products and some of the initiatives. One of the comments you made was that your 2012 guidance takes into account kind on some of the ongoing uncertainties. Could you elaborate a little bit about what are you taking into account and how you built up the 2012 expectations?

Peer Schatz

Sure. The guidance reflects the very balanced views of the risks and opportunities that we see in 2012 based on the variables that we feel comfortable in putting into the equations at the moment. As we all know, there remain great uncertainties in the macroeconomic environment. They are far from over. And I think companies have started to become better at managing them including us. There are still a lot of question marks out there that are impacting public funding and academic research and in the healthcare system. So that said, we are taking a balanced view on these risks, and at the same time, the opportunities that we are creating for ourselves to create an outlook. That if you look at the second half of 2011 shows a nice trajectory and continuation of a growth trend that we have proven already in the second half of 2011.

Quintin Lai – Robert W. Baird

And then kind of as a follow-up to that, when you are – it seems like that, when we are in these periods of uncertainty, the one thing that really resonates with customers that might be more frugal are new products and QIAsymphony certainly has gotten a lot of traction. Can you tell us a little bit about is it diagnostics, is it academic, is it Pharma, where are you seeing kind of the most uptick now?

Peer Schatz

Sure. It’s really across the customer classes. In each of the customer class, we have dedicated investment criteria for the development of new products and programs. And if you look at the content rollout that we have personalized healthcare, virology, and also in the other infectious disease and genetics areas, it’s a quite a record rollout in particular in Europe, but also the U.S. submissions are quite a few. And this is something that we have the list on one of the slides and clearly we have to hope to add more to that list in addition to what we have shown here. So, there is a lot of opportunity that we have in terms of menu expansion in diagnostics with the existing platforms in the rollout phase that we have today.

In the applied markets, the rollouts in particular in the forensic area and food testing area are going very well. The porting of these assays over to the QIAsymphony system, the creation of complete packages is resonating very well. And I’d say there is certainly an innovative aspect to that, but it’s just a breakthrough utility proposition that we are giving in that applied testing area, which was typically running very cluttered, not very integrated or very streamlined workflows. And we are creating a very nice work flow from sample to result for assays that have become quite routine and this is clearly seen as a breakthrough in many areas.

In the academic research area, as you know, there are few products that generally do more than $10 million in sales and a portfolio in the research area is one typically defined by a strategic focus and ours is sample and assay technologies. We will be launching one to two dozen new products this year that are quite innovative in various sample preparations for several types of applications that preferred to announce them when they come forward. But there is a significant R&D resource base that is allocated towards the life science research markets. But what we are doing in both life science research and pharma is not only platform technologies, but content.

I think few people recognize this, but if you look at QIAGEN today, one of the major revenue sources is actually content diagnostic content, life science content, applied testing content that we sell in the form of test. And we will expand – further expand that content offering that was increased quite significantly in 2011 through 100s of new mutation assays that we put on to GeneGlobe system in addition to the gene expression portfolio and epigenetic portfolio. So, there is a lot going on that is starting to link the academic and the pharma world that are actually working very closely together.

Quintin Lai – Robert W. Baird

Thank you.

Peer Schatz

Next question?

Operator

And the next question comes from Mr. Schenkel. Please state your name, company name followed by your question.

Doug Schenkel – Cowen and Company

Hi, good morning and good afternoon. This is Doug Schenkel from Cowen and Company.

Peer Schatz

Good morning, Doug

Doug Schenkel – Cowen and Company

Peer, maybe a high level question for you. Clearly, the business environment remains difficult, but through this period, it will be fair you've been aggressively investing you deployed almost $1 billion on acquisitions and about $500 million on R&D. And recognizing this if 2012 organic revenue guidance plays out as you guys have outlined, I think this would be the third straight year of low single-digit organic growth. What do you believe the long-term growth rate is of your business? Do you think that coming out of 2012 that will hit some inflection point? And then I guess for Roland what growth rate do you need to achieve in 2013 to get to that 31% operating margin target exiting the year?

Peer Schatz

Okay, Doug, I’ll take the first part of the question, Roland, the second. I appreciate your comments. However, I don’t think it’s the third year, I think it’s the second year in a row we had quite a good performance in 2009 coming in actually ahead of our expectations on the top-line that are quite strong. So, if you look at 2011 and 2012, we clearly had some very difficult time, the healthcare industry overall, the one thing however, I'd like to note is that we are gaining market share in all markets that we currently serve. So, we have been outperforming growth in the overall Molecular Diagnostics market with an outperforming growth in the Life Science research markets and even in Pharma and Applied Testing if you take 2010 and 2011 together we've been outperforming growth there as well.

So, there is a macro trend and there is a micro trend and clearly there is a lot that we can improve on. I also recognize your statement on the acquisitions and the R&D spent. At the same time if you note that in 2006, 2005, we generated 60% to 70% of our sales in the academic research market. This is today about 25%. I don't think the business would show anywhere close to these growth rates if it just an academic research supply business and the critical mass would not be there.

So, we transitioned the company into a much stronger strategic position going forward with a longer growth profile in front of it and as you see from QIAsymphony one that is for instance just unfolding the personalized medicine. So, are we focused on driving our growth rate up absolutely, and everything we're doing is targeting in that direction and I think if you look into further out years, you see some trends coming stronger into fruition than what we've seen or what we will see in 2012. It just doesn't make sense at this moment to project across the growth three times the market growth rate in 2012 and you are seeing most other parties come out with conservative guidance at the moment that we think if we look at our guidance at the moment in balance, it allows us to continue to build our growth initiatives and we think it is a prudent thing to do at this moment.

We are however, managing for a maximization of the top-line growth opportunity that we have. Roland, you want to add to that?

Roland Sackers

Sure, yeah, that just to I don't what Peer said, 2009 organic growth rate was 13% by the way.

Doug Schenkel – Cowen and Company

Yeah, I was actually sorry. I was talking about '10 or '11 and the guidance for '12 so that's all I got for the three years kind of '11 and '12 in terms of what you guided to, yeah, obviously '09 was a good year for you guys.

Roland Sackers

And but going back to the second part of the question, which is what is the underlying growth rate required to go to the margin what we believe is very valid here, I would answer in the first way as also looking back actually to 2011. So, one thing, I think, which is, I think, essential to understand is that we have actually a very good increase quarter-over-quarter in terms of those revenue growth as well as in terms of profitability and also the second half of the year at the end of the day, was, I think, a good finish for us for the – and also I would like to remind you that especially in terms around profitability we also made our guidance as we said earlier in the year of 2011 because you have to remind we clearly amounted that we have a $0.02 dilution from the Cellestis acquisition.

Having that all I said, I do believe that we have a significant leverage within our cost opportunities that one is efficiency program, which we started in 2011 will lead over the more efficient programs we are now executing on in 2012 into higher profitability for 2013. And in general, I would also assume that kind of a solid mid single-digit growth rate would be already sufficient. So, if you come above that, we have, I think even a good chance to be significantly over achieving our profitability target going forward.

Nevertheless, I think all of my view important is we have a good leverage scale in terms of profitability in terms of cost. We have a proven track record of having our hands around our cost situation as well.

Doug Schenkel – Cowen and Company

Okay, that's really helpful, it's early just the point is early to get it, how you guys are thinking about running the business operationally moving forward so, I appreciate the color. One very quick follow-up in the press release you talked about, I think single-digit growth in the kit business on the academic side, which is good. Could you provide any more color on how that part of the business is holding up more broadly across different end markets and more specifically what’s going on in terms of pricing? Thank you again.

Peer Schatz

Sure, Doug. I think the academic markets are facing a shift in terms of consumer behavior that we haven’t seen in quite a few years, 10 to 15 years or so. It’s quite impressive to see how everybody is preparing for the new, more difficult funding environment in academia. Back to the comment I made before, I don’t believe that the academic markets as and overall market provide growth for the next 5 maybe even 10 years as public funding will always be constrained. However, there is room for technology-driven growth in pockets and as the public funding shifts the higher growth areas. For instance, our MI clinical content offerings and platforms are being perceived quite nicely and that is why we are achieving above market growth in this area. Professionalization of purchasing the alliances with pharmaceutical company is becoming tighter and more formalized. All this is significantly changing the way that commercialization is being done in the academic research markets.

We have as one of the efficiency programs significantly stepped up our direct marketing efforts of a much broader reach now into the market and instead of only having a field sales force we are and we have expanded the customer touch point significantly with electronic and other matters. And that is working very nicely for us in the regions where we have implemented. So, there is really a lot of underlying change that you can't really just explain in a very simple way, because a lot of consumer behavior is changing quite considerably as we speak. Operator, next question please.

Operator

Thank you. The next question comes from Ms. Koshal. Please state your name, company name, followed by your question.

Nandita Koshal – Barclays Capital

Good morning. This is Nandita Koshal from Barclays Capital.

Roland Sackers

Hi Nandita.

Nandita Koshal – Barclays Capital

Good morning. I have a question on the impact of mix on margins. So, in profiling, firstly what is the economics to QIAGEN look like on the consumables pull-through on the QIAsymphony system, especially on the non-branded piece, the LDTs that seemed to be a pretty meaningful proportion?

Peer Schatz

Sure, Roland, you want to address that?

Roland Sackers

Yeah, sure. One other thing also quite obvious out of the numbers we delivered over the course of 2011 is that profiling is, in the meantime, as we said also quite meaningful business for us. And of course with the success of QIAsymphony, it’s getting even more important for us. And therefore, it is clearly also focused for us to in terms of margin expansion to drive the portfolio to a new level if you like. On the instrumentation part of the business, we are clearly missing the upfront revenue recognition part, as most of our customers especially in the diagnostics side want to have kind of reagent renter contract instead of a straight line sale of the instrument, which rather than clearly gives us a typically 3 to 5-year contact this customer. On the margin side, typical consumable margins also for the profiling product and so I think it is something what actually over time will be beneficial to our portfolio.

Peer Schatz

If I may add to that, Nandita, really a typical LDT would be composed of sample preparation and assay platform technology. Reagents would probably end up at cost of around $5, $6 depending on the application. They are typical, let's say, commercial HIV test, viral load test, and by the way, recently, they are winning a lot of prizes right now in scientific publications book hepatitis C and HIV test that are running on the Symphony. They cost around $25, let's say. And however, the upfront cost is more significant due to the validation. So, the margin on the reagents as you know is usually in the high 70s on the assay, on the commercial assay as well, but you have the regulation, the burden of the validation and the development process, which is obviously much more onerous. So, we like to have this mix. The LDT portfolio is actually very profitable for us as well and gives us a much broader menu very quickly. And there are even a lot of customers exchanging now the LDT recipes on the QIAsymphony platform.

Nandita Koshal – Barclays Capital

That’s very helpful color. And also in personalized healthcare, Peer what sort of uptake pricing and margin assumptions do you have for, say the first couple of FDA approved Gear assets from over say 12 to 18 months after launch.

I’m basically trying to figure out the dynamics of this maturing companion diagnostic partnership pipeline, which were seems to be a lower margin companion diagnostic milestone payment versus the commercialized assay revenues and the profitability on those?

Peer Schatz

I think we have to differentiate between the development work, which is in FTE service basically, where we act like a CRO basically and charge the FTE services at a certain margin. These margins are not really what we’re after we are more after the product and the product typically as a high margin and prices of the KRAS test for instance in depending on the country can usually be a $150 to $200 the cost of a product is comparable to the cost of an HIV product.

So, there's a little bit more complexity to it, but not much. So, the margins of a commercial kit product are very high. The margins on the development services that should be dwarfed by the kit sales over time. The margins on the development services are below average.

Nandita Koshal – Barclays Capital

I see. As we ramp up on the commercial assays and I don’t know if you can share some assumptions around the initial ramp up. But is it fair to assume that the bulk of personalized healthcare revenues growth will come from companion the CDx milestone payments in the near-term -- near to medium term? Thank you.

Peer Schatz

No, Nandita, the bulk of the revenue is already today coming from kit sales. That is ramping up very rapidly. So, the development milestones or services are smaller portion of the overall sales base.

Roland Sackers

Nandita you will find a slide on that in the recent analyst presentation, conference presentation we did also. A detailed slide on that for your reference.

Nandita Koshal – Barclays Capital

Thank you gentlemen.

Peer Schatz

We will send it to you.

Albert Fleury – Director IR North America

Thank you. Operator?

Operator

The next question is from Mr. Peterson. Please state your name, company name, followed by your question.

Tycho Peterson – JPMorgan

Thank you. It’s Tycho Peterson from JPMorgan. Peer, regards to your comments in the academic market if we look back not too long ago you had talked about accelerating some of your direct sales channels stepping up some of your direct marketing efforts.

If I listen to your commentary now it’s a little bit more cautious on the margin then we’ve heard from some of your peers that have reported on at least the near-term trends. Can you talk to maybe some of the underlying dynamics there, I mean you’re getting traction from this refocused sales effort on the academic side and what do you see as the opportunity for market share again if you will?

Peer Schatz

In the academic market?

Tycho Peterson – JPMorgan

Correct.

Peer Schatz

Yeah. If you look at the growth numbers that we are pulling in the academic markets and you isolate them out to direct peers that are have already reported, you see that were gaining share. Some are reported, have reported negative numbers, others very low single-digit numbers and we are above that.

So the traction that we have in this market is that we are positioned us a company that transitions from life science research through to clinical through to applications that are getting closer to the patient and this is an area that is getting more funding. So, that’s the big differentiator compared to the typical purely academic basic research supplier that you might be peering to us. That’s why we are getting higher growth.

Tycho Peterson – JPMorgan

Okay. On QIAsymphony you put a wide range of the utilization numbers out there. How should we think about with the menu expansion this year? How should we think about where utilization is and where that could go and can you also talk to the percentage of placements now that are maybe competitive wins versus Abbott or Roche, or how many of those are alternatively upgrades?

Peer Schatz

Sure. There is a big difference between the U.S. and Europe. In Europe, we have over 20 assays running on the system including all the big blood virals. We’re winning a lot of the direct comparisons and I’d like to refer to the some of the publications that have come out in scientific journals highlighting the significant improved automation workflow and convenient for customers compared to the competing systems. So, we're winning both on automation menu and also the quality of individual assets. I won't go into direct wins and this is a market that many players in there and we don't particularly all this individual customers. But we are very successful in Europe on all those three firms. In the United States, we clearly have a menu build-up phase, which is more owners due to the regulatory requirement. But this is the menu starting to move forward especially in companion diagnostics we're building critical mass and for pathologists, very importantly, a pipeline…..

Tycho Peterson – JPMorgan

I mean are you able to talk it all, but where you think utilization in U.S. could be 12 months to 18 months down the road with a fuller menu?

Roland Sackers

We have a very clear idea where just go and significantly involved what we are today. I wouldn’t want to give a specific target right now because this would be very closely tied to our assay roadmap that we haven't disclosed in full detail. So, that the current numbers are currently still validation numbers and limited menu numbers and they are moving now and we hope that will move up quite significantly.

Peer Schatz

Operator, I'm sorry, we need to move on – we need to really limit this to one question per person because of the issue of time. We still have time for people. Thank you. I'm sorry.

Operator

The next question is from Mr. Groberg. Please state your name, company name followed by your question.

Jon Groberg – Macquarie

Great. Thanks. This is Jon Groberg from Macquarie. I just had one clarification in the slide and then one question. On the slide that we have the employee count, I know just curious coming to restructuring you announced what number of that expected to be by the end of 2012 and then my question, Peer, strategically as with Roche going after Alumina and curious about year-over-year, they need to have may be a more substantial position in the sequencing space given your focus on personalized medicine and some of the target therapeutic areas that you're going after. I know you have a small business there – a small technology there, but just may be you can talk strategically. Thanks.

Peer Schatz

Sure, Ronald, you want to take this second – the first question?

Roland Sackers

On the headcount side, first of all you have to have in mind, of course, given the different employee laws especially also in Germany and U.S. that as we announced, we clearly will – are expecting a reduction of 8% to 10% of headcount is not reflected in the end of December number even if most people find the agreement in December, they typically have an employment at the end of the year so, that's something what you will see over the course of the first quarter fading into the number. And on the other end, we clearly – as Peer joined the call – call as well as we're going to invest in other areas as well. So, at the end of the day we would assume we have a lower number of not necessarily 8% to 10%.

Peer Schatz

Okay, the second part of the question the recent consolidations in the space clearly emphasized two things, it's one is the importance of personalized medicine going forward in a various trends that is taking in number two is the importance also sequencing. The importance of sequencing is primarily focus on the Life Science research market. The move into clinical applications is still targeting more niche application, we'll take some time, the reason is that the validation of multi-gene parameters is extremely expensive in personalized medicine, and the roadmap to get there is still not clear.

It will depend on the geography and on the application so the majority of the applications that are coming into us are single gene or multi-gene panels that are very well manageable at a very acceptable cost on real-time PCR multiplex platforms and Pyrosequencing. The situation might change in 5 to 10 years and this is something that we clearly recognized we have received offers for access to platform because again we are not a platform play, but a content play and had a significant portfolio of content that we can port over to any platform that would make sense so, this is the roadmap that we have to laid out and we feel comfortable.

Jon Groberg – Macquarie

Thank you.

Peer Schatz

Thank you.

Operator

The next question is from Mr. Wales. Please state your name, company name, followed by your question.

Martin Wales – UBS

Hello, it’s Martin Wales from UBS.

Peer Schatz

Hi, Martin.

Martin Wales – UBS

From QIAsymphony, clearly, you have seen something north of 150 machines placed in 2011. You're going for north of 200, sorry, in 2012. What’s driving acceleration, is it the content? Is it the redundancy with the (LDT front end) to the system fully, what’s driving enough, and I guess, where you think it can go longer term?

Peer Schatz

The QIAsymphony system is by far the most versatile molecular processing platform in the industry. So, this is evidenced by the current placement of 550 systems in the record time as we just really rolled out the consumables and first menu basically starting mid 2000 and probably to the research markets and then sometime early 2011 to the diagnostic market. So, there is a significant runway in front of us that we think we can address. And I wouldn't want to put an overall market side, but it’s definitely a four-digit number and that’s let’s say if you see other systems out there, that is selling 2,000 to 3,000 units a year. This should be or that have a placement of 2000 to 3000 units, these are market sizes that are not unreasonable. Competing products in the market from other competitors have high 100 number, 700, 800 systems or maybe 1500 system in some cases, but these are by far the leading systems in the market. And if you look at the numbers that we have at the moment we are reaching very quickly towards those numbers with clear intent to surpass them.

Martin Wales – UBS

And given that the RGQ front end drives a much up bigger consumable stream per instrument, I gather that majority of machines placed last year had RGQ, but then you are expecting something similar this year. But overall still the minority of instruments have the RGQ front-end, how should we think about revenues per instrument developing across 2012?

Peer Schatz

The majority of our customers were actually RGQs detection customers and they acquired the QIAsymphony to synthesize a full QIAsymphony RGQ by themselves. There are several thousands of RGQs out there. And in some cases the Symphony’s were added to their workflow to add a complete – to create a complete system. And that is a good chunk of the placements that we have out there are therefore QIAsymphony RGQs by definition.

Martin Wales – UBS

(indiscernible).

Peer Schatz

50,000 to 60,000 currently, but we are driving that out very quickly as the validation of periods are completing and some customers are well into several hundreds of thousands of dollars.

Martin Wales – UBS

Okay, I'll leave that. Thank you very much.

Peer Schatz

Thank you.

Operator

The next question is from Mr. Quirk. Please state your name, company name, followed by your question.

Bill Quirk – Piper Jaffray

Thanks. Good afternoon. Bill Quirk from Piper Jaffray.

Peer Schatz

Hi Bill.

Bill Quirk – Piper Jaffray

Hi, good morning or good afternoon. Question and a quick follow-up, first off, Ronald thanks very much for the color around the margins. Just help us think a little bit about 2012, because in the release you also noted that there was some pressure from some HPV pricing deals as well as obviously just mix as it relates to the instrument. So, if you could give us a little more color there. And then as a follow-up or perhaps a un-related follow-up, Peer, just thinking about some of the changes upfront in the Molecular Diagnostic space for reimbursement, then it's going to be directly affecting you guys or maybe you could speak to longer term implications here? Thanks guys.

Roland Sackers

Yeah. Let me go other explain during the call and also in the press release, I would expect that 2012 in terms of gross margin probably back it is low 70s. The fourth quarter 2011 was clearly an exception. There is a couple of things coming together, especially all to the change in inventory levels by the move there in Germany in terms of production. And so I guess that is the significant one-time effect and also remember of co-development project in one quarter was exceptionally high. First thing it shouldn’t go out to the business on a yearly basis, so I guess we have a good chance here, with also the additional leverage programs going on to go back to the 70s never even including a certain price pressure situation on the HPT fund in the U.S. On operating margin, just to conclude on that we stick very firm to our $31 adjusted EBIT growth at the end of 2013.

Peer Schatz

Great and the first question Bill, as you point out correctly the implications are not too direct for us at the moment. The one thing that we have been very actively working on is the reimbursement of companion diagnostics moving close back into targeted reimbursement codes. That has seemed to be quite favorable for U.S. It’s not quite complete, but we are looking at making companion diagnostics and attractive proposition also for pathology customers in addition to the healthcare system overall.

Bill Quirk – Piper Jaffray

Thanks guys.

Peer Schatz

Thanks.

Operator

The next question is from Mr. Zana. Please state your name, company name, followed by your question.

Romain Zana – Exane BNP Paribas

Hi gentlemen. This is Romain Zana speaking from Exane BNP Paribas. I have a question actually on the profitability and on the top of the companion diagnostic milestones. I was wondering what were the impacts actually the magnitude of the impact on the gross margin from HPV pricing pressure on the full year 2011. And also if Roland, you could give us a fair assumption of what would be the gross margin level in 2012?

Roland Sackers

The second part that is probably around 70% probably and our goal is to have 70% fund and what I just said before as well. On the HPV side clearly 2011 year was different mix on the running side volume stabilization. But clearly entering in a significant number and extension of multiyear contracts, where we were able to sign our material contracts as you can view, which we believe is a significant success and probably what you should expect from the market leader.

But clearly pricing was a topic overall I’d say still moderate, but I think it’s nothing but should be unexpected and so it’s the question now also going now into 2012 if this is going to continue and as we said before we do believe so. I think pricing will be ongoing topic for our U.S. franchise on the HPV side. We don’t see HPV as a growth driver for the company in the U.S. Nevertheless we stick very firm to all of our franchise. We are the 1,000 market leader and we will be going forward as well.

Peer Schatz

Romain if I may just add to that if you look at the number 13% of sales being U.S. based HPV testing that you’re referring to. It would need huge swings in the pricing to really have a meaningful effect on the gross margin.

Romain Zana – Exane BNP Paribas

And what was the overall organic growth for HPV in 2011 in the U.S.?

Peer Schatz

What we looked at what we said also in previous calls is that the HPV portfolio did not grow in 2011 there was even a moderate decline. We expect a continuation of this trends flat or moderate decline in 2012 potentially.

It really depends on how the market stabilizes and moves forward, but we are in extremely strong competitive position that is what we’re focused on. So, we’re focused more on market conversion right now and expanding the base of laboratories that are using our test.

Romain Zana – Exane BNP Paribas

Okay. Thank you.

Peer Schatz

Thank you.

Operator

The next question is from Mr. Lawson. Please state your name, company name, followed by your question.

Peter Lawson – Mizuho Securities

This is Peter Lawson, Mizuho Securities. Peer just outside HPV of what’s been happening with the utilization rates and pricings of other clinical diagnostic assays in Q4 and the early part of Q1?

Peer Schatz

Sure, I assume you mean the United States or in Europe or any specific region because there are very different pricing dynamics.

Peter Lawson – Mizuho Securities,

Yeah, so if you could tackle the U.S. and then ex-U.S.?

Peer Schatz

Yes, so in the United States we have not necessarily seen significant price changes in the market, despite an industry having gone through a difficult period. The lab industry is definitely also had challenges in the form of stabilizing physician utilization trends. It’s starting to become a little less of an issue historically. So, going forward, we think that prices in the majority of our portfolio very robust.

In the other European markets, there is – it's a competitive market. Prices in Europe are typically significant and below where they are in the United States that's a very competitive market, much – I'd say much more transparent also in terms of competition and there we are very competitively priced and are gaining primarily in performance and menu and workflow. But we have not seen significant changes other than in more mature assays like Chlamydia or like, in some cases, assays like HIV where there is a significant price maturization that is moving into some of the assets, not all of them but some of them. Luckily, we have been able to get premium prices in most market.

Peter Lawson – Mizuho Securities,

Thank you, Peer, just is a follow-up FDA approvals that are expected for 2012.

Peer Schatz

We have the K-RAS assay into different versions in front of the FDA. We have an influenza vaccine in front of the FDA and we saw two versions of CMV assay, one a pre-molecular QuantiFERON version and one a molecular quantitative version of CMV. These are the ones that we put out for now. There are other submissions that we expect to do as well.

Peter Lawson – Mizuho Securities,

Those are the ones that you expect approvals in 2012.

Peer Schatz

With the exception of CMV viral load that could take longer time until the approval. This is a submission in 2012. Hence, a longer review would happen.

Peter Lawson – Mizuho Securities,

Great, thanks so much.

Peer Schatz

Thank you.

Albert Fleury – Director IR, North America

And with that, I would like to close, this is Al Fleury from QIAGEN again, by thanking you all for participating. If you have any further questions, please do not hesitate to contact either John Gilardi or myself. Thank you very much.

Peer Schatz – Chief Executive Officer

Thank you very much.

Operator

That concludes the Q4 investor and analyst conference call of QIAGEN N.V. Thank you for participating. You may now disconnect.

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